PANOURA 18S

PREMARKET NOTIFICATION 510(k)

Section 6- 510(k) Summary

JUL 13 2011
a. Owner/Company name, address
THE YOSHIDA DENTAL MFG. Co., LTD.
1-3-6, Kotobashi, Sumida-ku
Tokyo
130-85 16, Japan

Michizo Yamanaka
President

IContact person
Hidenori Watanabe
International Regulatory Affairs
Phone: 011-81- 3-3631-2165
Fax: 011-81- 3-3633-9420
Email: hi-watanabe~yoshida-net.cojp

b. Contact/Application Correspondent
Fumiaki Kanai, Ph.D.
President and CEO
MIC International
4-1-17 Blongo, Bunkyo-ku
Tokyo, 113-0033, Japan

Phone: 011-81-3-3818-8577
Fax: 011-81-3-3818-8573
Email: kanaif@mici.cojp

c. Date prepared
April 29, 2011

d. Name of device
Trade Name: PANOURA 188
Common Name: Extraoral source x-ray system
Classification Name: System, x-ray, extracral source, digital
Classification Regulation: 21 CER 872.1800

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APRIL 29, 2011 6- 2 OF 6-7
PANOtJRA 18S
PREMARKET NOTIFICATION 5 10(k)

e. Predicate devices
The PANOURA 18S is substantially equivalent to the following legally marketed device:

510(k): K093683
Trade name: ORTHOPANTOMOGRAPH 0P300
Product code: MUR

The predicate device is hereinafter called "the ORTHOPANTOMOGRAPH (k093683)" in this

application.

f. Description of the device

The PANOURA 18S dental panoramic and cephalometric device is intended for dental
radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray
images as well as X-ray projection images. The PANOURA 18S is equipped with an X-ray
generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit.
While rotating around the patient's teeth and jaw, the PANOURA 18S irradiates X-ray and
detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are
transferred to an image processing unit and the data are superimposed with appropriate shift
value according to the X-ray moving speed from the arm rotation to acquire image.

g. Indications for Use

The PANOURA 18S dental panoramic and cephalometric device is intended for dental
radiographic examinations of teeth, jaw and TMJ areas by producing coniventional 2D X-ray
images as well as X-ray projection images. The device must only be operated and used by
dentists and other legally qualified professionals.

h. Statement of substantial equivalence

The characteristics of the PANOURA 18S are similar to those of the ORTHOPANTOMOGRAPH
(k093683) listed in part e. The similarities are:

* Intended use
* Operational characteristics
* Ionizing radiation
* Cephalometric radiogram
* Panoramic images by producing conventional 2D X-ray images as well as X-ray
projection images

Difference regarding intended use between the PANO1JRA 18S and the
ORTHOPANTOMOGRAPH (k093683) is that the ORTH-OPANTOMOGRAPH (k093683) has
following additional intended use compared to the PANOUR A 18S:

1. Cone Beam Computerized Tomography

2. Producing X-ray projection of 3-D

In order to evaluate safety and effectiveness of the PANOURA 18S, software

verification/validation, performance testing, and risk analysis were performed. In conclusion,

THE YOSHIDA DENTAL MFG. CO., LTD. SECTION 6

APRIL 29, 2011 6- 3 OF 6-7
PANOURA 1S
PREMARKET NOTIFICATION 510(k)

those testing and analysis demonstrated that the PANOURA I 8S did not raise any new safety
or effectiveness concerns compared to the ORTHOPANTOMOGRAPH (k093683)

i. Comparison table
Table 6-1 compares the characteristics between the PANOURA I18S and the
ORTHOPANTOMOGRAPH (k093683).

THE YOSHIDA DENTAL MEG. CO., LTD. SECTION 6

APRIL 29, 2011 6- 4 OF 6-7
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PANOURA I18S
PREMARKET NOTIFICATION 5 10(k)

j. Compliance with recollnized consensus or voluntary standards

The following recognized consensus or voluntary standards were used (as applicable) for
the Bxtraoral source x-ray system classified in 21 CFR 872.1800. The PANOURA 18S Meets
the requirements of the recognized consensus or voluntary standard.

Standards S-tanda rds . Standards Title Date

No. Organization _______________________________

60601-1 UL Medical Electrical Equipment, Part 1: General Requirements for 2003

Safety, Al: 1991/A2: 1995
Medical electrical equipment - Part 1-2: General requirements for
60601-1-2 lEG basic safety and essential performance - Collateral standard: 2004
Electromagnetic compatibility - Requirements and tests. Al :2004
Medical electrical equipment - Part 1-3: General requirements for
60601-1-3 LEG basic safety and essential performance - Collateral Standard: 1994
Radiation protection in diagnostic X-ray equipment
60601-2-7 lEG Medical
the safetyelectrical equipment
of high-voltage - Part 2-7: Particular requirements for
generators of diagnostic X-ray generators 1998
__

Medical electrical equipment - Part 2-28: Particular requirements

60601-2-28 LEC for the basic safety and essential performance of X-ray tube 1993
___________assemblies for medical diagnosis
60601-2-32 lEG Medical electrical equipment - Part 2: Particular requirements for 19
the safety of associated equipment of X-ray equipment 19
60825-1 IEG Safety of laser products - Part 1: Equipment classification and* 2007
requirements
Evaluation and routine testing in medical imaging departments -
61223-3-4 IEC Part 3-4: Acceptance tests - Imaging performance of dental X-ray 2000
_________ __________equipment

62304 LEG Medical device software - Software life cycle processes 2006
14971 IOMedical devices - Application of risk management to medical 2007
_________ __ ____ ___ devices

k. Conclusion
The PANOURA 18S has the same intended use except regarding computerized tomography
and reconstructed 3-D image and similar operational and technological characteristics as the
ORTHOPANTOMOORAPH (k093683). The performance test results indicate that the PANOURA
18S meets the requirements of recognized consensus or voluntary standard. Based on the
information presented above regarding substantial equivalence to the
ORTHOPANTOMOORAPH (k093683), THE YOSIDA DENTAL MFG. Co., LTD. concludes that the
PANOURA 18S is substantially equivalent to the ORTEOPANTOMOORAPH (k093683) and does
not raise any new questions regarding safety or effectiveness.

THE YOSHIDA DENTAL MFG, CO., LTD. SECTION 6

APRIL 29, 2011 6- 7 OF 6-7
4 DEP3ARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Roomn - W066-6609
Silver Spring, MD 20993-0002

The Yoshida Dental MFG Co., Ltd.

% Fumaki Kanai, Ph.D.
President and CEO
MIC International
4.1.17 Hongo, Bunkyo-ku
Tokyo, 113-0033
JAPAN

Re: K1112313
Trade/Device Name: Panoura 18S 2A
Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral source x-ray system
Regulatory Class: 11
Product Code: MUH
Dated: April 29, 2011
Received: May 2, 2011

Dear Dr. Kanai:

We have reviewed your Section 5 10(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.

If your device is classified (see above) into class 11 (Special Controls), it may be subject to such
additional controls. Existing major regulations affecting your device can be found in Title 21,
Code of Federal Regulations (CER), Parts 800 to 895. In addition, FDA may publish further
announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act's requirements, including, but not limited to: registration and listing'(21
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice
requirements as set forth in the quiality systems (QS) regulation (21 CER Part 820). This letter
will allow you to begin marketing your device as described in your Section 5 10(k) premarket
notification. The FDA finding of substantial equivalence of your device to a legally marketed
predicate device results in a classification for your device and thus, permits your device to
proceed to the market.

If you desire specific advice for- your device on our labeling regulation (21 CFR Parts 801 and
809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-
5450. Also, please note the regulation entitled, "Misbranding by reference to premarket
notification" (21 CER Part 807.97). For questions regarding the reporting of adverse events
under the MDR regulation (21 CFR Part 803), please go to
http://w-ww-A.fda.g~ov/MedicalDevices/Safety/Repoi-taproblem/default.htm for the Office
-LRHs
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on youir responsibilities under the Act from thle
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 6389-2041 or (301) 796-7100 dr at its Internet address
http://www.fda. gov/cdrlindustry/support/index.htrnl.

Sincerely Yours,

Mary S. Pastel, Se.D.

Director
Division of Radiological Devices
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center forf Devices and RadiologicalJ-Health

Enclosure
 Indications for Use

5 10(k) Number (if known): _ _

Device Name: PANOIIRA 18S

Indication for Use

The PANOUR-A I 8S dental panoramic and cephalometric device is intended for dental
radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray
images as well as X-ray projection images. The device must only be operated and used by
dentists and other legally qualified professionals.

Prescription Use X _ AND/OR Over-the Counter Use ___

(Per 21 GFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ionign-off)o

Division of Radiological Devices

Ofie of In vitro Diagnostic Device Evaluation and Safety

510K